IMPORTANCE Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence... Show moreIMPORTANCE Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. OBJECTIVE To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. DESIGN, SETTING, AND PARTICIPANTS This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. EXPOSURE Hemiarthroplasty using PLA or DLA. MAIN OUTCOME AND MEASURES The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. RESULTS A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31(95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. CONCLUSIONS AND RELEVANCE This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04438226 Show less
Scheper, H.; Mahdad, R.; Elzer, B.; Lowik, C.; Zijlstra, W.; Gosens, T.; ... ; Wound Care App Study Grp 2023
Background: Differentiation between uncomplicated and complicated postoperative wound drainage after arthroplasty is crucial to prevent unnecessary reoperation.Prospective data about the duration... Show moreBackground: Differentiation between uncomplicated and complicated postoperative wound drainage after arthroplasty is crucial to prevent unnecessary reoperation.Prospective data about the duration and amount of postoperative wounddrainage in patients with and without prosthetic joint infection (PJI) are currently absent.Methods: A multicentre cohort study was conducted to assess the duration and amount of wound drainage in patients after arthroplasty. During 30 postoperative days after arthroplasty, patients recorded their wound status in a previously developed wound care app and graded the amount of wound drainage on a 5-point scale. Data about PJI in the follow-up period were extracted from the patient files.Results: Of the 1019 included patients, 16 patients (1.6 %) developed a PJI. Minor wound drainage decreased from the first to the fourth postoperative week from 50 % to 3 %. Both moderate to severe wound drainage in the third week and newly developed wound drainage in the second week after a week without drainage were strongly associated with PJI (odds ratio (OR) 103.23, 95 % confidence interval (CI)26.08 to 408.57, OR 80.71, 95 % CI 9.12 to 714.52, respectively). Thepositive predictive value (PPV) for PJI was 83 % for moderate to heavy wound drainage in the third week. Conclusion: Moderate to heavy wound drainage and persistent wound drainage were stronglyassociated with PJI. The PPV of wound drainage for PJI was high for moderate to heavy drainage in the third week but was low for drainage in the first week. Therefore, additional parameters are needed to guide the decision to reoperate on patients for suspected acute PJI. Show less
Scheper, H.; Mahdad, R.; Elzer, B.; Löwik, C.; Zijlstra, W.; Gosens, T.; ... ; Wound Care App Study Grp 2023
Background: Differentiation between uncomplicated and complicated postoperative wound drainage after arthroplasty is crucial to prevent unnecessary reoperation. Prospective data about the duration... Show moreBackground: Differentiation between uncomplicated and complicated postoperative wound drainage after arthroplasty is crucial to prevent unnecessary reoperation. Prospective data about the duration and amount of postoperative wound drainage in patients with and without prosthetic joint infection (PJI) are currently absent. Methods: A multicentre cohort study was conducted to assess the duration and amount of wound drainage in patients after arthroplasty. During 30 postoperative days after arthroplasty, patients recorded their wound status in a previously developed wound care app and graded the amount of wound drainage on a 5-point scale. Data about PJI in the follow-up period were extracted from the patient files. Results: Of the 1019 included patients, 16 patients (1.6 %) developed a PJI. Minor wound drainage decreased from the first to the fourth postoperative week from 50 % to 3 %. Both moderate to severe wound drainage in the third week and newly developed wound drainage in the second week after a week without drainage were strongly associated with PJI (odds ratio (OR) 103.23, 95 % confidence interval (CI) 26.08 to 408.57, OR 80.71, 95 % CI 9.12 to 714.52, respectively). The positive predictive value (PPV) for PJI was 83 % for moderate to heavy wound drainage in the third week. Conclusion: Moderate to heavy wound drainage and persistent wound drainage were strongly associated with PJI. The PPV of wound drainage for PJI was high for moderate to heavy drainage in the third week but was low for drainage in the first week. Therefore, additional parameters are needed to guide the decision to reoperate on patients for suspected acute PJI. Show less
Loggers, S.A.I.; Willems, H.C.; Balen, R. van; Gosens, T.; Polinder, S.; Ponsen, K.J.; ... ; FRAIL-HIP Study Grp 2022
IMPORTANCE Decision-making on management of proximal femoral fractures in frail patients with limited life expectancy is challenging, but surgical overtreatment needs to be prevented. Current... Show moreIMPORTANCE Decision-making on management of proximal femoral fractures in frail patients with limited life expectancy is challenging, but surgical overtreatment needs to be prevented. Current literature provides limited insight into the true outcomes of nonoperative management and operative management in this patient population. OBJECTIVE To investigate the outcomes of nonoperative management vs operative management of proximal femoral fractures in institutionalized frail older patients with limited life expectancy. DESIGN, SETTING, AND PARTICIPANTS This multicenter cohort studywas conducted between September 1, 2018, and April 25, 2020, with a 6-month follow-up period at 25 hospitals across the Netherlands. Eligible patientswere aged 70 years or older, frail, and institutionalized and sustained a femoral neck or pertrochanteric fracture. The term frail implied at least 1 of the following characteristicswas present: malnutrition (body mass index [calculated asweight in kilograms divided by height in meters squared] <18.5) or cachexia, severe comorbidities (American Society of Anesthesiologists physical status class of IV or V), or severe mobility issues (Functional Ambulation Category similar to 2). EXPOSURES Shared decision-making (SDM) followed by nonoperative or operative fracture management. MAIN OUTCOMES AND MEASURES The primary outcomewas the EuroQol 5 Dimension 5 Level (EQ-5D) utility score by proxies and caregivers. Secondary outcome measures were QUALIDEM (a dementia-specific quality-of-life instrument for persons with dementia in residential settings) scores, pain level (assessed by the Pain Assessment Checklist for Seniors With Limited Ability to Communicate), adverse events (Clavien-Dindo classification), mortality, treatment satisfaction (numeric rating scale), and quality of dying (Quality of Dying and Death Questionnaire). RESULTS Of the 172 enrolled patients with proximal femoral fractures (median [25th and 75th percentile] age, 88 [85-92] years; 135women [78%]), 88 opted for nonoperative management and 84 opted for operative management. The EQ-5D utility scores by proxies and caregivers in the nonoperative management group remained within the set 0.15 noninferiority limit of the operative management group (week 1: 0.17 [95% CI, 0.13-0.29] vs 0.26 [95% CI, 0.11-0.23]; week 2: 0.19 [95% CI, 0.10-0.27] vs 0.28 [95% CI, 0.22-0.35]; and week 4: 0.24 [95% CI, 0.15-0.33] vs 0.34 [95% CI, 0.28-0.41]). Adverse eventswere less frequent in the nonoperative management group vs the operative management group (67 vs 167). The 30-day mortality rate was 83%(n = 73) in the nonoperative management group and 25%(n = 21) in the operative management group, with 26 proxies and caregivers (51%) in the nonoperative management group rating the quality of dying as good-almost perfect. Treatment satisfaction was high in both groups, with a median numeric rating scale score of 8. CONCLUSIONS AND RELEVANCE Results of this study indicated that nonoperative management of proximal femoral fractures (selected through an SDM process) was a viable option for frail institutionalized patients with limited life expectancy, suggesting that surgery should not be a foregone conclusion for this patient population. Show less
Noorduyn, J.C.A.; Teuwen, M.M.H.; Graaf, V.A. van de; Willigenburg, N.W.; Schavemaker, M.; Dijk, R. van; ... ; Escape Res Grp 2021
Purpose Although physical therapy is the recommended treatment in patients over 45 years old with a degenerative meniscal tear, 24% still opt for meniscal surgery. The aim was to identify those... Show morePurpose Although physical therapy is the recommended treatment in patients over 45 years old with a degenerative meniscal tear, 24% still opt for meniscal surgery. The aim was to identify those patients with a degenerative meniscal tear who will undergo surgery following physical therapy. Methods The data for this study were generated in the physical therapy arm of the ESCAPE trial, a randomized clinical trial investigating the effectiveness of surgery versus physical therapy in patients of 45-70 years old, with a degenerative meniscal tear. At 6 and 24 months patients were divided into two groups: those who did not undergo surgery, and those who did undergo surgery. Two multivariable prognostic models were developed using candidate predictors that were selected from the list of the patients' baseline variables. A multivariable logistic regression analysis was performed with backward Wald selection and a cut-off of p < 0.157. For both models the performance was assessed and corrected for the models' optimism through an internal validation using bootstrapping technique with 500 repetitions. Results At 6 months, 32/153 patients (20.9%) underwent meniscal surgery following physical therapy. Based on the multivariable regression analysis, patients were more likely to opt for meniscal surgery within 6 months when they had worse knee function, lower education level and a better general physical health status at baseline. At 24 months, 43/153 patients (28.1%) underwent meniscal surgery following physical therapy. Patients were more likely to opt for meniscal surgery within 24 months when they had worse knee function and a lower level of education at baseline at baseline. Both models had a low explained variance (16 and 11%, respectively) and an insufficient predictive accuracy. Conclusion Not all patients with degenerative meniscal tears experience beneficial results following physical therapy. The non-responders to physical therapy could not accurately be predicted by our prognostic models. Show less
Background: The posterolateral approach (PLA) and direct lateral approach (DLA) are the most commonly used approaches for inserting a hemiarthroplasty in the treatment of femoral neck fractures. A... Show moreBackground: The posterolateral approach (PLA) and direct lateral approach (DLA) are the most commonly used approaches for inserting a hemiarthroplasty in the treatment of femoral neck fractures. A recent review concluded that the routine use of PLA should be questioned, but this conclusion itself can be questioned. The aim of this study is to provide an updated overview and critical appraisal of the available evidence, focussing on outcomes most relevant for patients. Methods: We conducted a comprehensive search of literature in the MEDLINE and EMBASE databases and Cochrane Library. Studies (till June 2018) to identify hip fracture clinical trials/comparative studies comparing alternative surgical approaches (PLA and DLA). We explored sources of heterogeneity and conducted pooled analyses when appropriate. Results: 264 potentially eligible studies were identified of which 1 RCT, 3 prospective, 3 registry data and 5 retrospective studies were included. The RCT consisted performance and attrition bias. The mean MINORS score of the prospective/register studies was 17.3 (SD 3.5) and 13.8 (SD 1.9) of the 5 retrospective studies. The GRADE score for all the outcomes was very low. Due to the high and various types of biases across the included studies, we did not pool the data. None of studies assessed the activities of daily living functionality. 6 studies reported significantly more dislocations or reoperations due to dislocation in the PLA group, 6 other studies found no differences. DLA patients were more likely to develop abductor insufficiency leading to limping and more need for walking aids. The PLA patients tended to have better quality of life, less pain and more satisfaction compared to the DLA patients. Conclusion: Based on low-quality studies, PLA may be associated with more dislocations, but patients had less walking problems and a lower tendency to abductor insufficiency compared with DLA. Further clinical trials with methodology rigor are needed to determine which approach is more effective in terms of outcomes relevant to patients. Show less
